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| Name | Class |
|---|---|
| Bezmialem Vakif University | OTHER |
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The purpose of this study is to compare the effects of an 8-week supervised downhill walking training program, prescribed based on the 6-minute walk test, on functional capacity, peripheral muscle strength, and cardiovascular responses in individuals with type 2 diabetes mellitus, as compared to a level walking training program.
Participants who agree to take part in the study will be randomly assigned to either the downhill or the level-ground walking group. Both groups will undergo a 6-minute walk test (6MWT) at the beginning of the study, and participants will then undergo an 8-week walking training program-conducted twice a week on a treadmill under the supervision of a physical therapist-in which their walking speed is determined based on their average speed during the 6MWT and gradually increased, with the duration of the sessions also being extended.
Participants will do the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Downhill Walking | Experimental |
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| Level Walking | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Downhill Aerobic Walking Training | Other | This involves performing a progressive aerobic exercise program-prescribed based on the results of a 6-minute walk test-twice a week for 8 weeks, at a constant 10-degree downhill, under the supervision of a physical therapist. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-Minute Walk Test (6MWT) | The 6DYT is a walking test used to assess a participant's submaximal exercise capacity, during which the participant walks for six minutes at a self-determined pace. The patient walks as far as possible along a 30-meter corridor for six minutes. The total distance walked during the test will be recorded in meters as the primary outcome measure. | From baseline to the end of treatment at 8 weeks |
| Measurement of Peripheral Muscle Strength | Muscle strength measurements for hip extension, knee extension, knee flexion, and ankle plantar flexion will be performed using a handheld dynamometer. A dynamometer is a device that enables more quantitative measurements; the person conducting the test holds it in their hand to perform manual muscle testing. Different body segments have different pads. The muscles will be properly positioned and assessed. For each muscle group, measurements will be performed 3 to 5 times on both the right and left extremities, and the peak force will be recorded for each muscle group. Results will be recorded in Newtons. | From baseline to the end of treatment at 8 weeks |
| Heart Rate Variability (HRV) - Root Mean Square of Successive Differences (RMSSD) | Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability. A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection. After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken. The collected data will be analyzed using the Kubios HRV (v1.7.13, Kubios Oy, Kuopio, Finland) mobile app. The software's automatic artifact correction algorithm will be used to remove signal noise. The RMSSD values will be recorded in milliseconds (ms) as a key indicator of parasympathetic activity. | From baseline to the end of treatment at 8 weeks |
| Heart Rate Variability (HRV) - Standard Deviation of NN Intervals (SDNN) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meryem Bektaş Karakuş | Contact | +90216 500 41 95 | meryem.bektas@acibadem.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezmialem Vakıf University Dragos Hospital | Recruiting | Istanbul | Maltepe | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Level Aerobic Walking Training | Other | This involves performing a progressive aerobic exercise program-prescribed based on the results of a 6-minute walk test-twice a week for 8 weeks, at a constant 0-degree (i.e., level) slope, under the supervision of a physical therapist. |
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| Home exercise session | Other | It involves assigning the distance walked during that week's exercise session-conducted under the supervision of a physical therapist-as homework to be walked at home on one day of the same week. |
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Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability. A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection. After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken. The collected data will be analyzed using the Kubios HRV (v1.7.13, Kubios Oy, Kuopio, Finland) mobile app. The software's automatic artifact correction algorithm will be used to remove signal noise. The SDNN values will be recorded in milliseconds (ms) to reflect overall autonomic variability. |
| From baseline to the end of treatment at 8 weeks |
| Heart Rate Variability (HRV) - Mean RR Interval | Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability. A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection. After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken. The collected data will be analyzed using the Kubios HRV (v1.7.13, Kubios Oy, Kuopio, Finland) mobile app. The software's automatic artifact correction algorithm will be used to remove signal noise. The Mean RR values will be recorded in milliseconds (ms) to indicate the average time between heartbeats. | From baseline to the end of treatment at 8 weeks |
| Heart Rate Variability (HRV) - LF/HF Ratio | Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability. A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection. After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken. The collected data will be analyzed using the Kubios HRV (v1.7.13, Kubios Oy, Kuopio, Finland) mobile app. The software's automatic artifact correction algorithm will be used to remove signal noise. The LF/HF ratio will be recorded as a dimensionless value summarizing the sympathovagal balance. | From baseline to the end of treatment at 8 weeks |
| Fatigue Severity Scale (FSS) | The Fatigue Severity Scale is a 9-item measure that assesses the severity of fatigue and how it affects a person's activities. Participants respond to each item on a Likert scale ranging from 1: "I strongly disagree" to 7: "I strongly agree." The total score on the scale ranges from a minimum of 9 to a maximum of 63. Higher scores indicate more severe fatigue and greater impairment. The use of this scale is recommended for assessing fatigue in patients with type 2 diabetes. | From baseline to the end of treatment at 8 weeks |
| Blood Test Results: Glycated Hemoglobin (HbA1c) | HbA1c levels will be measured to assess participants' long-term glycemic control and the metabolic effects of the exercise training. The blood sample will be ordered by the attending physician and analyzed using standard laboratory methods. Results will be reported as a percentage (%). | From baseline to the end of treatment at 8 weeks |
| Blood Test Results: Fasting Blood Glucose (FBG) | Fasting blood glucose levels will be measured to assess participants' current metabolic status. The blood sample will be ordered by the attending physician after an overnight fast and analyzed using standard laboratory methods. Results will be reported in milligrams per deciliter (mg/dL). | From baseline to the end of treatment at 8 weeks |
| Lipid Profile: Low-Density Lipoprotein (LDL) Cholesterol | LDL cholesterol levels will be measured for the purposes of cardiovascular risk management and monitoring metabolic adaptation. The blood sample will be ordered by the attending physician and analyzed using standard laboratory methods. Results will be reported in milligrams per deciliter (mg/dL). | From baseline to the end of treatment at 8 weeks |
| Lipid Profile: High-Density Lipoprotein (HDL) Cholesterol | HDL cholesterol levels will be measured for the purposes of cardiovascular risk management and monitoring metabolic adaptation. The blood sample will be ordered by the attending physician and analyzed using standard laboratory methods. Results will be reported in milligrams per deciliter (mg/dL). | From baseline to the end of treatment at 8 weeks |
| Lipid Profile: Triglycerides | Triglyceride levels will be measured for the purposes of cardiovascular risk management and monitoring metabolic adaptation. The blood sample will be ordered by the attending physician and analyzed using standard laboratory methods. Results will be reported in milligrams per deciliter (mg/dL). | From baseline to the end of treatment at 8 weeks |
| D004700 | Endocrine System Diseases |